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NCT00833521 · ClinicalTrials.gov registry record · Phase 1
Zolpidem Tartrate 10 mg Tablets Under Fasting Conditions
A Phase 1 study, sponsored by Teva Pharmaceuticals USA.
- Completed
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
NCT00833521: Completed Phase 1 study, sponsored by Teva Pharmaceuticals USA.
NCT00833521 is a Phase 1 study that has completed, run by Teva Pharmaceuticals USA. The registered enrollment target is 38 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00833521, a Phase 1 study, has completed, sponsored by Teva Pharmaceuticals USA.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
Study Summary
The objective of this study is to compare the relative bioavailability of Zolpidem tartrate 10 mg tablets (manufactured by TEVA Pharmaceutical Industries, Ltd. and distributed by TEVA Pharmaceuticals USA) with that of AMBIEN® tablets(G.D. Searle \& Co.) in healthy, adult, non-smoking subjects under fasting conditions.
Primary Outcome
Bioequivalence based on Cmax
Interventions
- DRUG Zolpidem 10 mg tablets
- DRUG AMBIEN® 10 mg tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2002-02 |
| Est. Completion | 2002-02 |
| Phase | Phase 1 |
What the finished NCT00833521 record still lists
NCT00833521 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower).
The record links to 0 conditions, and to 2 interventions - of which Zolpidem 10 mg tablets is the first listed.
NCT00833521 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00833521 about?
NCT00833521 is a clinical study titled "Zolpidem Tartrate 10 mg Tablets Under Fasting Conditions". The objective of this study is to compare the relative bioavailability of Zolpidem tartrate 10 mg tablets (manufactured by TEVA Pharmaceutical Industries, Ltd. and distributed by TEVA Pharmaceuticals USA) with that of AMBIEN® tablets(G.D. Searle \& Co.) in healthy, adult, non-smoking subjects under ...
What is the current status of trial NCT00833521?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2002-02. Estimated completion is 2002-02.
What interventions are being tested in trial NCT00833521?
The interventions under investigation include: Zolpidem 10 mg tablets (DRUG), AMBIEN® 10 mg tablets (DRUG).
Who is sponsoring clinical trial NCT00833521?
This trial is sponsored by Teva Pharmaceuticals USA, which has 83 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00833521's enrollment target sits among peer trials
38 1197th of 2000 higher than 797 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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